Month: January 2019

CLASSIFICATION OF MEDICAL DEVICES

Medical Devices are any instrument, appliance, machine, software or any other device including part or accessory of a device which is

  • Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them
  • Intended to diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”

FDA has categorized classifications of nearly around 1,700 different generic types of devices and collected them into 16 medical specialties referred to as panels. Medical devices are classified in to Class I, Class II or Class III depending upon the risk of the device.

  • Class I devices are in general recognized as low risk devices with general controls with or without exemptions.
  • Class II devices are in general recognized medium risk to the user with general controls and Special control with or without exemptions.
  • Class III devices are recognized as high risk device that support life, and present high risk of illness and injury. Class III devices requires general controls, special controls and also premarket approval.

Classification of devices depends upon the intended use and indications for use of the device. Device classification can be found in two ways, one is to check at Classification database or can be checked at device panel at which the device belongs to.

Companies that involved in manufacturing and distribution of medical devices intended for commercial distribution are required to register with FDA annually and pay fees. Most companies are required to list their devices and need to notify the activities done on those devices at their establishment.

If a device requires Premarket notification (510K) or Premarket approval (PMA) or Humanitarian Device Exemption (HDE), the owner/operator should get above clearance from FDA before they start marketing the device in US.

All Medical devices marketed in United States has be in compliance with FDA labeling requirements, if not, FDA will considered them as misbranded.

Liberty Management Group Ltd, provides assistance with medical device establishment registration, device listings, label review and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us

www.fdahelp.us

HOMEOPATHIC DRUG REGISTRATION AND LISTING WITH FDA

Homeopathy is an alternative medicine created by a German Scientist which claims that a substance that causes the symptoms of a disease in healthy people would cure similar symptoms in sick people.

Any drugs labeled as homeopathic has to be listed in the Homeopathic Pharmacopeia of the United States (HPUS).

FDA does not approve products labeled as homeopathic products. The products labeled as homeopathic contains a range of substances resulting from plants, healthy or dead animal or human sources, minerals and chemicals.

Homeopathic products currently marketed here in US have not been reviewed by FDA to check its safety and effectiveness to treat, diagnose, cure or prevent any disease or conditions.

Under FD&C act, Homeopathic drugs products are subject to same regulations as OTC drugs.

As per FDA, companies which manufacture, prepare, propagate and compound homeopathic drugs must register with FDA as drug establishment and list their drugs with FDA by creating a SPL.

Homeopathic drug product labeling must comply in same regulations as any other drugs products.

Liberty Management Group Ltd, provides assistance with homeopathic drugs establishment registration, drug listings and US agent service to foreign facilities.

Sudha S

Regulatory Consultant

Mail : office@libertymanagement.us.

www.fdahelp.us

COMPOUNDING PHARMACY REGISTRATION

Compounding is a method of mixing, combines or alters ingredients of a drug to manufacture a medication custom made to the needs to individual patient under the supervision of licensed pharmacist, or a licensed physician or an outsourcing facility.

Compounded drugs are not FDA-approved. FDA does not check these drugs to assess their safety or efficiency before they reach patients. It is only the responsibility of State board of pharmacy to monitor state-licensed pharmacies that compound drugs in accordance with regulation of section 503A of the FD&C, although FDA has some control over their operations.

Outsourcing facilities registered under section 503B are regulated by FDA and must stratify cGMP requirements and will be inspected by FDA.

An outsourcing facility is geographic location or address where the drugs are compounded. An outsourcing facility has to be in compliance with section 503B and must comply with cGMP requirements.

If an outsourcing facility engages in compounding non-sterile drugs and animal drugs, mixing, diluting or repacking biological products do not need to register as an outsourcing facility as the drugs compounded are not eligible for exemption form 503B for FD&C act.

All Outsourcing facilities that engages in compounding sterile human drugs needs to register with FDA using CEDR system.

All outsourcing facilities must renew their registration between Oct 1st and Dec 31st and pay the annual establishment registration fees for every year as long as they wish to register as an outsourcing facility.

PRODUCT REPORTING PROCEDURES

The drug products manufactured from December 1 through May 31 must submit drug product reporting between June 1 and June 30. In the same way, the drug products manufactured from June 1 through November 30 must submit drug product reporting between December 1 and December 30.

Each product report must include all sterile and non-sterile drug compounded in the outsourcing facility must include active ingredient and its strength, NDC number of source drug or bulk active ingredient, dosage and route of administration, package description, number of individual units manufactured and NDC number of end product (If assigned)

LMG provide assistance with FDA registration of Outsourcing facilities.

Sudha S

Regulatory Consultant

Mail – office@libertymanagement.us

http://www.fdahelp.us

Published on: January 9, 2019